Events

Recall of Chocolate II Agar (GC II Agar with Hemoglobin and Iso Vitalex), microbiological media plates, Catalog #221267, packaged in cardboard carton, 100 plates per carton.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Becton Dickinson & Co.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    27551
  • Event Risk Class
    Class 3
  • Event Number
    Z-0164-04
  • Event Initiated Date
    2003-10-10
  • Event Date Posted
    2003-11-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-06-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30052
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Culture Media, For Isolation Of Pathogenic Neisseria - Product Code JTY
  • Reason
    Microbiological media may exhibit reduced colony size of bacteria, haemophilus species.
  • Action
    The recalling firm notified distributors by fax and end users by certified mail on 10/10/03. The recall notice advised consignees of reduced growth of Haemophilus species, and instructed them to discontinue distribution and use and discard product for replacement. The letter requests consignees to respond with replacement units needed.

Device

Chocolate II Agar (GC II Agar with Hemoglobin and Iso Vitalex), microbiological media plates, Cat...
  • Model / Serial
    Lot/EXP 3197678/ November 13, 2003*** 3197693/ November 14, 2003*** 3198565/ November 07, 2003*** 3212853/ November 25, 2003*** 3212901/ November 27, 2003*** 3212919/ November 28, 2003*** 3212956/ December 02, 2003*** 3212972/ December 03, 2003***
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was sold to domestic distributors and direct shipped end users nationwide including government consignees, and was additionally sold to affiliated international distributors.
  • Product Description
    Chocolate II Agar (GC II Agar with Hemoglobin and Iso Vitalex), microbiological media plates, Catalog #221267, packaged in cardboard carton, 100 plates per carton.
  • Manufacturer
    Becton Dickinson & Co

Manufacturer

Becton Dickinson & Co
  • Manufacturer Address
    Becton Dickinson & Co, 7 Loveton Cir, Sparks MD 21152-9212
  • Source
    USFDA